A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures

NCT01972256 | Completed

• 1 other identifier: PR-0023
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to demonstrate the relative efficacy of two lumbar fusion procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or bilateral posterior pedicle screw fixation as an adjunct to fusion, in comparison to transforaminal lumbar interbody fusion (TLIF) when used in conjunction with unilateral or bilateral supplemental screw fixation as an adjunct to fusion. Subject candidates are those who had previously required and received fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).

Conditions

Pseudoarthrosis; Spinal Stenosis; Spondylolisthesis; Degenerative Disc Disease (DDD)

Outcome Measures

Primary Outcomes (1)

• Efficacy

  Fusion of the targeted vertebral bodies (L4-L5-S1) at 24 months as determined by independent orthopedic surgeon reviewer interpretation of high resolution Computed Tomography (CT) scan.

  Assessed at 2 years post-op or greater

Secondary Outcomes (1)

• Safety

  2 years post-op

Other Outcomes (1)

• Additional Secondary Endpoint: Efficacy

  Assessed at 2 years post-op

Study Arms (2)

Previous transsacral fusion

Subject candidates are those who had required a transsacral fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).

Previous transforaminal lumbar interbody fusion

Subject candidates are those who had required transforaminal lumbar interbody fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject candidates are those who had required fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).

You may qualify if:

• Adult 18 years of age or older
• Male or female subject that had previously received the transsacral two-level procedure when used in conjunction with pedicle screw or facet screw fixation or TLIF two-level procedure with unilateral or bilateral supplemental screw fixation (e.g. pedicle screws, facet screws at L4-L5-S1 to treat pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD)
• Subject that was treated no less than 2 years prior to this evaluation with an transsacral or TLIF procedure by the participating surgeons
• Subject that had a diagnosis that required a transsacral or TLIF procedure at the L4-L5-S1 levels and did not require treatment at any other lumbar levels at the time of surgery

You may not qualify if:

• Subject who did not receive the transsacral or TLIF procedure for fusion of L4-L5-S1
• Subject who received lumbar fusion procedures at levels other than L4-L5-S1 at the time of surgery

Sponsors & Collaborators

• Baxano Surgical, Inc.: lead

Study Sites (5)

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33637, United States

Location

Indiana Spine Group

Indianapolis, Indiana, 46032, United States

Location

Bone and Joint Clinic of Baton Rouge

Baton Rouge, Louisiana, 70808, United States

Location

Michigan Spine Institute

Waterford, Michigan, 48327, United States

Location

Brazos Spine

College Station, Texas, 77845, United States

Location

MeSH Terms

Conditions

Pseudarthrosis; Spinal Stenosis; Spondylolisthesis; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Fractures, Ununited; Fractures, Bone; Wounds and Injuries; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: October 30, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

US (5)